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Trial · NCT01268683

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of EnrollmentDay 1The number of months to enroll 10 participants.
PrimaryPercentage of Enrolled Participants to Screened ParticipantsDay 1
PrimaryPercentage of Participants Completing 90-Day Follow-UpDay 90
PrimaryPercentage of Dose Reductions/ Dose SuspensionsUp to Day 3
PrimaryPercentage of Participants With All Four MRI Assessments Per ProtocolUp to Day 3
PrimaryNumber of MRI Assessments Per ParticipantUp to Day 3
PrimaryPercentage of Participants Requiring One or More Hypoglycemia TreatmentsUp to Day 4
PrimaryPercentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to ProtocolUp to Day 4
SecondaryNumber of Participants With Adverse Events and Serious Adverse EventsUp to Day 90
Adverse Events (AE's) of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all Severe Adverse Events (SAE's) will be followed for 90 days. SAE's and AE's were reviewed, and the number of participants with unanticipated adverse events, or drug-related SAE's were assessed.
SecondaryInfarcted Hemisphere VolumeBaseline, Day 1, Day 2, and Day 3
SecondaryAbsolute Diffusion Weighted Imaging (DWI) Lesion VolumeBaseline, Day 1, Day 2, and Day 3
SecondaryChange From Baseline in DWI Lesion VolumeBaseline, Day 1, Day 2, and Day 3 (Day 3 reported)
SecondaryMidline ShiftBaseline, Day 1, Day 2, and Day 3
SecondaryIpsilateral Ventricle VolumeBaseline, Day 1, Day 2, and Day 3
SecondaryFrequency of Hemorrhagic EventsDay 1, Day 2, and Day 3
SecondaryNational Institute of Health Stroke Scale (NIHSS) ScoreBaseline, Day 1, Day 2, Day 3, and Day 7
The NIHSS is composed of 11 categories, each of which is scored between 0 and 4. A score of 0 indicates normal function, a higher score indicates more impairment. Category scores are summed to generate the total NIHSS score (possibles scores range from 0-42).
SecondaryGlasgow Coma Scale (GCS) ScoreBaseline, Day 1, Day 2, Day 3, and Day 7
The GCS is scored on a scale between 3 and 15 (3 = the worst, and 15 = best). It is composed of three parameters : Best Eye Response (scored on a scale of 1-4), Best Verbal Response (scored on a scale of 1-5), Best Motor Response (scored on a scale of 1-6)
SecondaryFull Outline of UnResponsiveness (FOUR) ScoreBaseline, Day 1, Day 2, Day 3, and Day 7
The FOUR Score is a 17-point scale (with potential scores ranging from 0 - 16). Decreasing FOUR Score is associated with worsening level of consciousness. The FOUR Score assesses four domains of neurological function: eye responses, motor responses, brainstem reflexes, and breathing pattern.
SecondaryNumber of Participants Requiring Decompressive Craniectomy (DC)Up to Day 90
SecondaryNumber of Participants With a Modified Rankin Scale (mRS) Score ≤ 4Day 30, Day 90
The mRS scale runs from 0-6, the scoring is as follows: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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